Gingival RecessionNCT07104019
Biofiller and Gingival Phenotype Thickening
A study testing Biofiller Injection and connective tissue graft in people with Gingival Recession and Gingival Diseases, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The periodontal phenotype is defined as the combination of the gingival phenotype and the thickness of the buccal bone plate (bone morphotype). The gingival phenotype refers to the gingival thickness (GT) and the width of the keratinized tissue (KTW). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Gingival Diseases, Gingival Inflammation
- What is being tested?
- Biofiller Injection and connective tissue graft
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 60 years
- Systemically healthy individuals
- Presence of thin gingival phenotype in the mandibular anterior region (canine to canine)
- No medications that affect wound healing
- No history of bleeding disorders
- No known allergy to anti-inflammatory drugs
Show all 9Show fewer
- Not pregnant or breastfeeding
- Willingness to participate and provide informed consent
- Non-smoker
Who cannot join
- Systemic diseases (e.g., diabetes, hypertension, cancer, etc.)
- Use of medications that may affect healing (e.g., corticosteroids, immunosuppressants)
- History of radiotherapy or chemotherapy
- Pregnancy or breastfeeding
- Poor oral hygiene
- Refusal to participate
Show all 9Show fewer
- Age under 18 years
- Smoking
- Presence of Class II or Class III orthodontic anomalies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Inonu university
Malatya, 44000
Kubra Aral, phd, 00903410106 ext. 6250, kubra.aral@inonu.edu.tr
About this study
Official title: Evaluation of the Effectiveness of Blood Concentrate Biofiller in Thickening the Gingival Phenotype Around Natural Teeth
The periodontal phenotype is defined as the combination of the gingival phenotype and the thickness of the buccal bone plate (bone morphotype). The gingival phenotype refers to the gingival thickness (GT) and the width of the keratinized tissue (KTW). A gingival thickness of ≤1 mm is classified as a thin phenotype, whereas a thickness >1 mm is considered a thick phenotype. Thin gingival biotypes tend to show more pronounced responses to inflammation, restorations, trauma, and parafunctional habits. Various methods are used to assess gingival thickness, including transgingival probing (TP), ultrasonic measurements, cone-beam computed tomography (CBCT) scans, visual assessment, and colored biotype probes (CBP). Periodontal plastic procedures performed using autogenous grafts such as connective tissue grafts (CTG) and free gingival grafts (FGG), or biomaterials such as acellular dermal matrices (ADM) and collagen matrices (CM), are known to significantly increase GT and the amount of keratinized tissue. However, creating a second surgical site in the oral cavity during these procedures may compromise patient comfort, prompting researchers to explore alternative methods. Additionally, the effectiveness of synthetic biomaterials has been found to be lower than that of autogenous grafts.
Platelet-rich concentrates have been used as a minimally invasive procedure for the past thirty years, showing a high capacity to release growth factors that support tissue regeneration. While platelet-rich plasma (PRP), as the first-generation platelet concentrate, is widely used, platelet-rich fibrin (PRF) has been increasingly applied across various fields of medicine and dentistry due to its ability to release more growth factors over a longer period, resulting in better clinical outcomes. PRF is a highly biocompatible material composed of autologous cells and growth factors entrapped in a fibrin matrix, and has been shown to degrade more slowly over time compared to conventional PRP. One of the main reported disadvantages of PRF (and especially PRP) is its relatively rapid resorption, typically within 2-3 weeks. Biofiller is an autologous material derived from the patient's own blood and includes platelet-poor plasma (PPP) and concentrated platelet-rich fibrin (PRF). The PPP component is heated to become enriched with albumin, thereby prolonging its resorption time. The PRF portion contains autologous cells and growth factors. However, conventional PRF is typically resorbed within 2-3 weeks, limiting its clinical application. Recent studies have shown that the resorption time of biofiller-a combination of PPP and PRF-can exceed 4 months.
The aim of this study is to compare the effectiveness of biofiller with connective tissue graft in increasing gingival thickness in patients with a thin gingival phenotype. A total of 34 patients (17 patients in each group) will be enrolled. Tunnel surgery will be performed to all participants and test group will receive biofiller only once. Control group will receive connective tissue surgery. Clinical parameters obtained from our patients at baseline and at follow-up visits at 1, 3, and 6 months - including gingival thickness (GT), keratinized tissue width (KTW), and soft tissue measurements assessed via intraoral scanners - will be compared.
Read the detailed description
The periodontal phenotype is determined by gingival thickness (GT), the width of keratinized tissue (KTW), and buccal bone thickness. A thin phenotype (GT ≤1 mm) is more susceptible to inflammation, trauma, and surgical complications. To increase soft tissue thickness, autogenous grafts such as connective tissue grafts (CTG) or biomaterials like collagen matrices are used. However, autogenous grafts require a second surgical site, which may reduce patient comfort.
Biofiller is a novel autologous material prepared by heating platelet-poor plasma (PPP) and combining it with concentrated platelet-rich fibrin (c-PRF), resulting in a biocompatible gel with prolonged resorption time and regenerative potential.
This randomized controlled clinical trial aims to compare the effectiveness of Biofiller versus connective tissue graft in increasing gingival thickness in patients with a thin gingival phenotype.
In the literature, several clinical indications have been proposed for phenotype modification in individuals with a thin phenotype, such as prior to orthodontic treatment, when implant placement is planned, or when a restoration is intended to be placed subgingivally. Therefore, all participants in this study will undergo an orthodontic evaluation prior to treatment.
A total of 34 systemically healthy patients with a thin phenotype in the mandibular anterior region will be enrolled. All participants will undergo a standardized tunneling procedure (canine to canine). The test group will receive a single injection of 0.5 mL Biofiller per tooth, while the control group will receive a connective tissue graft.
To ensure standardization, individuals with Class II or Class III orthodontic anomalies will be excluded. Lateral cephalometric radiographs will be obtained to measure buccal bone thickness at three points per tooth, and an average value will be calculated. Only patients with a Class I skeletal relationship and an orthodontic treatment indication will be included.
Clinical parameters including GT, KTW, and digital soft tissue thickness (via intraoral scanner) will be recorded at baseline, and at 1, 3, and 6 months.
- Conditions
- Gingival Recession, Gingival Diseases, Gingival Inflammation
- Being tested
- Biofiller Injection, connective tissue graft
- Keywords
- biofiller, gingival phenotype modification, connective tissue graft
- Medical subject headings
- Gingival Recession, Gingival Diseases, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofiller InjectionProcedure or surgery
Also called Albumin-enriched Platelet-Rich Fibrin injection
Biofiller will be prepared by heating the platelet-poor plasma (PPP) component obtained from peripheral blood, which is then mixed with concentrated PRF (c-PRF). After creating a surgical tunnel in the mandibular anterior region (canine to canine), 0.5 mL of the prepared biofiller will be injected into each tooth region under the gingiva. The procedure is performed under local anesthesia and aims to increase gingival thickness in patients with a thin periodontal phenotype.
connective tissue graftProcedure or surgery
Also called Autogenous Connective Tissue Graft
A connective tissue graft will be harvested from the palatal donor site and placed under the gingiva using a minimally invasive tunneling technique in the mandibular anterior region (canine to canine). The procedure will be performed under local anesthesia and aims to increase gingival thickness. No biomaterials or adjunctive agents will be used.
| Study group | Role | What they receive |
|---|---|---|
| Biofiller Injection Group | Experimental | Patients in this group will receive biofiller composed of albumin-enriched platelet-poor plasma (PPP) and concentrated platelet-rich fibrin (c-PRF), prepared from the patient's autologous blood. After a tunneling procedure in the mandibular anterior region (canine-to-canine), 0.5 mL of biofiller will be injected per tooth Receives: Procedure: Biofiller Injection |
| connective tissue graft group | Active comparator | Participants in this group will undergo a minimally invasive tunneling surgical procedure in the mandibular anterior region (canine to canine). Autogenous connective tissue grafts (CTG) will be harvested from the patient's palate and placed under the gingiva through the tunnel to increase gingival thickness. The graft will be stabilized without vertical releasing incisions. No biomaterials or adjunctive agents will be used. All procedures will be performed under local anesthesia by an experienced periodontist. Receives: Procedure: connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival Thickness (GT)
Gingival thickness will be measured in the mandibular anterior region (canine to canine) using a digital caliper and intraoral scanner. The change in GT from baseline to each follow-up visit will be assessed to evaluate the efficacy of biofiller versus connective tissue graft in augmenting gingival thickness.
Measured: Baseline, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start30 Jul 2025
- Primary completion3 Nov 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, controlled, parallel-arm clinical trial designed to compare the efficacy of biofiller (albumin-enriched PRF) injection and connective tissue grafting in increasing gingival thickness in patients with thin periodontal phenotype.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Aral, Inonu University
- Investigators
- Kubra Aral, PhD, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104019
- Sponsor's protocol ID
- 2024-3647
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made available to other researchers due to ethical and privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Blood Concentrate Biofiller in Thickening the Gingival Phenotype Around Natural Teeth
- ClinicalTrials.gov ID
- NCT07104019
- Acronym / sponsor ID
- 2024-3647
- Conditions
- Gingival Recession, Gingival Diseases, Gingival Inflammation
- Keywords
- biofiller, gingival phenotype modification, connective tissue graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 3 Nov 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The periodontal phenotype is defined as the combination of the gingival phenotype and the thickness of the buccal bone plate (bone morphotype). The gingival phenotype refers to the gingival thickness (GT) and the width of the keratinized tissue (KTW). A gingival thickness of ≤1 mm is classified as a thin phenotype, whereas a thickness >1 mm is considered a thick phenotype. Thin gingival biotypes tend to show more pronounced responses to inflammation, restorations, trauma, and parafunctional habits. Various methods are used to assess gingival thickness, including transgingival probing (TP), ultrasonic measurements, cone-beam computed tomography (CBCT) scans, visual assessment, and colored biotype probes (CBP). Periodontal plastic procedures performed using autogenous grafts such as connective tissue grafts (CTG) and free gingival grafts (FGG), or biomaterials such as acellular dermal matrices (ADM) and collagen matrices (CM), are known to significantly increase GT and the amount of keratinized tissue. However, creating a second surgical site in the oral cavity during these procedures may compromise patient comfort, prompting researchers to explore alternative methods. Additionally, the effectiveness of synthetic biomaterials has been found to be lower than that of autogenous grafts.
Platelet-rich concentrates have been used as a minimally invasive procedure for the past thirty years, showing a high capacity to release growth factors that support tissue regeneration. While platelet-rich plasma (PRP), as the first-generation platelet concentrate, is widely used, platelet-rich fibrin (PRF) has been increasingly applied across various fields of medicine and dentistry due to its ability to release more growth factors over a longer period, resulting in better clinical outcomes. PRF is a highly biocompatible material composed of autologous cells and growth factors entrapped in a fibrin matrix, and has been shown to degrade more slowly over time compared to conventional PRP. One of the main reported disadvantages of PRF (and especially PRP) is its relatively rapid resorption, typically within 2-3 weeks. Biofiller is an autologous material derived from the patient's own blood and includes platelet-poor plasma (PPP) and concentrated platelet-rich fibrin (PRF). The PPP component is heated to become enriched with albumin, thereby prolonging its resorption time. The PRF portion contains autologous cells and growth factors. However, conventional PRF is typically resorbed within 2-3 weeks, limiting its clinical application. Recent studies have shown that the resorption time of biofiller-a combination of PPP and PRF-can exceed 4 months.
The aim of this study is to compare the effectiveness of biofiller with connective tissue graft in increasing gingival thickness in patients with a thin gingival phenotype. A total of 34 patients (17 patients in each group) will be enrolled. Tunnel surgery will be performed to all participants and test group will receive biofiller only once. Control group will receive connective tissue surgery. Clinical parameters obtained from our patients at baseline and at follow-up visits at 1, 3, and 6 months - including gingival thickness (GT), keratinized tissue width (KTW), and soft tissue measurements assessed via intraoral scanners - will be compared.
Detailed description
The periodontal phenotype is determined by gingival thickness (GT), the width of keratinized tissue (KTW), and buccal bone thickness. A thin phenotype (GT ≤1 mm) is more susceptible to inflammation, trauma, and surgical complications. To increase soft tissue thickness, autogenous grafts such as connective tissue grafts (CTG) or biomaterials like collagen matrices are used. However, autogenous grafts require a second surgical site, which may reduce patient comfort.
Biofiller is a novel autologous material prepared by heating platelet-poor plasma (PPP) and combining it with concentrated platelet-rich fibrin (c-PRF), resulting in a biocompatible gel with prolonged resorption time and regenerative potential.
This randomized controlled clinical trial aims to compare the effectiveness of Biofiller versus connective tissue graft in increasing gingival thickness in patients with a thin gingival phenotype.
In the literature, several clinical indications have been proposed for phenotype modification in individuals with a thin phenotype, such as prior to orthodontic treatment, when implant placement is planned, or when a restoration is intended to be placed subgingivally. Therefore, all participants in this study will undergo an orthodontic evaluation prior to treatment.
A total of 34 systemically healthy patients with a thin phenotype in the mandibular anterior region will be enrolled. All participants will undergo a standardized tunneling procedure (canine to canine). The test group will receive a single injection of 0.5 mL Biofiller per tooth, while the control group will receive a connective tissue graft.
To ensure standardization, individuals with Class II or Class III orthodontic anomalies will be excluded. Lateral cephalometric radiographs will be obtained to measure buccal bone thickness at three points per tooth, and an average value will be calculated. Only patients with a Class I skeletal relationship and an orthodontic treatment indication will be included.
Clinical parameters including GT, KTW, and digital soft tissue thickness (via intraoral scanner) will be recorded at baseline, and at 1, 3, and 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, controlled, parallel-arm clinical trial designed to compare the efficacy of biofiller (albumin-enriched PRF) injection and connective tissue grafting in increasing gingival thickness in patients with thin periodontal phenotype.
| Arm | Type | Receives |
|---|---|---|
| Biofiller Injection Group | Experimental | Procedure: Biofiller InjectionPatients in this group will receive biofiller composed of albumin-enriched platelet-poor plasma (PPP) and concentrated platelet-rich fibrin (c-PRF), prepared from the patient's autologous blood. After a tunneling procedure in the mandibular anterior region (canine-to-canine), 0.5 mL of biofiller will be injected per tooth |
| connective tissue graft group | Active comparator | Procedure: connective tissue graftParticipants in this group will undergo a minimally invasive tunneling surgical procedure in the mandibular anterior region (canine to canine). Autogenous connective tissue grafts (CTG) will be harvested from the patient's palate and placed under the gingiva through the tunnel to increase gingival thickness. The graft will be stabilized without vertical releasing incisions. No biomaterials or adjunctive agents will be used. All procedures will be performed under local anesthesia by an experienced periodontist. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 60 years
- Systemically healthy individuals
- Presence of thin gingival phenotype in the mandibular anterior region (canine to canine)
- No medications that affect wound healing
- No history of bleeding disorders
Key exclusion criteria (9 listed)
- Systemic diseases (e.g., diabetes, hypertension, cancer, etc.)
- Use of medications that may affect healing (e.g., corticosteroids, immunosuppressants)
- History of radiotherapy or chemotherapy
- Pregnancy or breastfeeding
- Poor oral hygiene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofiller InjectionAlso: Albumin-enriched Platelet-Rich Fibrin injectionBiofiller will be prepared by heating the platelet-poor plasma (PPP) component obtained from peripheral blood, which is then mixed with concentrated PRF (c-PRF). After creating a surgical tunnel in the mandibular anterior region (canine to canine), 0.5 mL of the prepared biofiller will be injected into each tooth region under the gingiva. The procedure is performed under local anesthesia and aims to increase gingival thickness in patients with a thin periodontal phenotype. | Procedure or surgery | Biofiller Injection Group |
| connective tissue graftAlso: Autogenous Connective Tissue GraftA connective tissue graft will be harvested from the palatal donor site and placed under the gingiva using a minimally invasive tunneling technique in the mandibular anterior region (canine to canine). The procedure will be performed under local anesthesia and aims to increase gingival thickness. No biomaterials or adjunctive agents will be used. | Procedure or surgery | connective tissue graft group |
Primary outcome
Change in Gingival Thickness (GT)
Time frame: Baseline, 1 month, 3 months, 6 months
Gingival thickness will be measured in the mandibular anterior region (canine to canine) using a digital caliper and intraoral scanner. The change in GT from baseline to each follow-up visit will be assessed to evaluate the efficacy of biofiller versus connective tissue graft in augmenting gingival thickness.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made available to other researchers due to ethical and privacy considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kubra Aral, PhD principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofiller Injection and connective tissue graft in people with Gingival Recession and Gingival Diseases, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kubra Aral, PhD (00903410106 ext. 6250, kubra.aral@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gingival Thickness (GT) (time frame: Baseline, 1 month, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025; AzTrials last refreshed its copy on 30 Oct 2026.